Climate Friendly and Ecological Food on Microbiota

NCT03383510 | Completed

• 1 other identifier: 2017/306
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate changes in nutrient intake, the human gut microbiota and pesticide excretion in urine when shifting from conventional food habits to sustainable food habits.

Conditions

Sustainability; Microbiota; Pesticides; Organic Food

Outcome Measures

Primary Outcomes (2)

• Changes in composition of the microbiota

  The investigators will assess changes over time in the presence of all gut bacteria species in the microbiome of the participants based on DNA sequencing from fecal samples. Samples will be collected at three occasions; baseline (reference sample), midtime (after 4 weeks) and at the end (after 8 weeks). From frozen samples, all DNA will be extracted and full shotgun metagenomic sequencing performed using next generation sequencing technologies (Illumina and BGISEQ). A total of 120 samples (3\*40 participants) will be sequenced to a depth of at least 3 giga base pairs (Gbp) each.

  Baseline, after 4 weeks, after 8 weeks

• Changes in concentration of pesticide residues in urine

  The investigators will assess changes in concentration of four pesticide residues (Mepiquat, Chlormequat, Propamocarb and Ethylene thiourea) excreted in urine. Samples will be collected at three occasions; baseline (reference sample), midtime (after 4 weeks) and at the end (after 8 weeks). The concentration of pesticide residues in urine samples will be determined in normal or reversed phase configuration on a high performance liquid chromatograph coupled to a triple quadrupole mass spectrometer (HPLC-MS/MS) system with electrospray ionization interface (ESI) run in negative or positive mode.

  Baseline, after 4 weeks, after 8 weeks

Secondary Outcomes (24)

• Changes in intake of energy

  After 8 weeks

• Changes in intake of protein

  Baseline, after 4 weeks, after 8 weeks

• Changes in intake of fat

  Baseline, after 4 weeks, after 8 weeks

• Changes in intake of carbohydrates

  Baseline, after 4 weeks, after 8 weeks

• Changes in intake of dietary fiber

  Baseline, after 4 weeks, after 8 weeks

Study Arms (4)

Climate friendly group

EXPERIMENTAL

The climate friendly group will receive instructions to eat according to a climate friendly diet, i.e., to replace the majority of their intake of animal based products with plant based food.

Other: Climate friendly diet

Organic group

EXPERIMENTAL

The organic group will receive instructions to eat an organic diet, i.e., to replace at least 50% of their normally consumed food with organic equivalents.

Other: Organic diet

Climate friendly and organic group

EXPERIMENTAL

The climate friendly and organic group will receive instructions to consume a climate friendly and organic diet, i.e, to replace the majority of their intake of animal based products with plant based food AND to consume at least 50% organic food products.

Other: Climate friendly and organic diet

Control group

PLACEBO COMPARATOR

The control group will receive instructions to eat according to the Nordic Nutrition Recommendations.

Other: Control group (Control diet)

Interventions

Climate friendly diet OTHER

Participants in the 'Climate friendly' group will be assigned a diet generating low emissions of greenhouse gases. The target is to reduce the participants' diet-related carbon dioxide equivalents (CO2e) to 2.5 kg per person and day, which is approximately a reduction by 50% compared the average CO2e, according to a previous study on diet-related CO2e in Sweden. The participants will be instructed to reduce their consumption of beef and dairy products and increase their consumption of plant-foods i.e. fruits, vegetables, legumes and whole-grain cereals.

Climate friendly group

Organic diet OTHER

Participants in the 'Organic group' will be assigned an organic diet with very low, or no, content of pesticides. The participants will be instructed to replace at least 50% of their food intake with organic foods.

Organic group

Climate friendly and organic diet OTHER

The participants in the 'Climate friendly and organic diet group' will be assigned a combination of a climate friendly and organic diet generating low emissions of greenhouse gas and having very low levels of pesticides. The target is to reduce the participants' diet-related CO2e to 2.5 kg per person and day. The participants will be instructed to replace at least 50% of their food intake with organic products.

Climate friendly and organic group

Control group (Control diet) OTHER

A conventional diet according to the Nordic Nutrition Recommendations (NNR). The participants will get information about the present dietary guidelines and how they can adhere to the guidelines, for example, by implementing the "plate model" for meals and learning about recommended levels of intake of macronutrients, micronutrients, fiber and energy.

Control group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Living in Västerås
• Carnivores
• Healthy

You may not qualify if:

• Vegans

Sponsors & Collaborators

• Mälardalen University: lead

Study Sites (1)

Mälardalens University

Västerås, 721 23, Sweden

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Katarina Bälter, PhD

  Mälardalens Högskola

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: December 26, 2017
• Study Start: August 31, 2017
• Primary Completion: May 3, 2018
• Study Completion: May 3, 2018
• Last Updated: June 12, 2018

Record last verified: 2018-06

Locations

SE (1)